ST Elevation Myocardial InfarctionNCT03156699
The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction
An observational study of ST Elevation Myocardial Infarction, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST Elevation Myocardial Infarction
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 30 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 STEMI patients treated with primary PCI.
Who may be able to join
- Look back to data at least 12 months old in order to ensure 6-week and 6-month follow up data is available. The inclusion criteria will be patients that presented with STEMI and were treated with primary PCI.
Who cannot join
- From the cath lab reports and clinical letters exclusions apply to patients that did not present with STEMI. In addition, patients that were not treated with primary PCI, or patients that deceased prior, during or post procedure (during hospitalization).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
About this study
This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. It is hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have incurred a higher degree of damage. As a result, it is hypothesised that these patients will have reduced LV (left-ventricular) systolic function, increased incidence of regional wall motion abnormalities (RWMAs), and increased troponin levels on admission. This study will additionally look for correlations between F-QRS and culprit vessels. To our knowledge there is minimal research regarding this.
Read the detailed description
This is a Physiological - Retrospective data collection from STEMI patients. Data from 100 STEMI patients treated with primary PCI will be extracted.
Data will be collected from presentation / initial admission, 6-week post-MI (Myocardial Infarction) clinic and 6 month post-MI clinic from the hospital system at New Cross Hospital. Data from admission includes; 12-lead ECG, echo reports and blood test results. Additionally, the 12-lead ECGs undertaken at 6-week and 6-months will be assessed for the presence of F-QRS.
- Conditions
- ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients treated with primary PCI | Database analysis only |
What is being measured
The primary outcome is the main question the study is designed to answer.
F-QRS measurements
recorded from ECG
Measured: Over 6 months
Secondary outcomes (2)
Left ventricular ejection fraction (LVEF)
recorded from ECG
Measured: Over 6 months
T-Troponin tests
T-Troponin tests as cardiac biomarker of myocardial damage
Measured: Over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Sep 2017
- Primary completion1 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joseph Kelly, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156699
- Sponsor's protocol ID
- 2017CAR93
- Status last verified
- Jun 2019
- First submitted
- 15 May 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03156699
- Acronym / sponsor ID
- 2017CAR93
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. It is hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have incurred a higher degree of damage. As a result, it is hypothesised that these patients will have reduced LV (left-ventricular) systolic function, increased incidence of regional wall motion abnormalities (RWMAs), and increased troponin levels on admission. This study will additionally look for correlations between F-QRS and culprit vessels. To our knowledge there is minimal research regarding this.
Detailed description
This is a Physiological - Retrospective data collection from STEMI patients. Data from 100 STEMI patients treated with primary PCI will be extracted.
Data will be collected from presentation / initial admission, 6-week post-MI (Myocardial Infarction) clinic and 6 month post-MI clinic from the hospital system at New Cross Hospital. Data from admission includes; 12-lead ECG, echo reports and blood test results. Additionally, the 12-lead ECGs undertaken at 6-week and 6-months will be assessed for the presence of F-QRS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients treated with primary PCI | – | –Database analysis only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 STEMI patients treated with primary PCI.
Key inclusion criteria (1 listed)
- Look back to data at least 12 months old in order to ensure 6-week and 6-month follow up data is available. The inclusion criteria will be patients that presented with STEMI and were treated with primary PCI.
Key exclusion criteria (1 listed)
- From the cath lab reports and clinical letters exclusions apply to patients that did not present with STEMI. In addition, patients that were not treated with primary PCI, or patients that deceased prior, during or post procedure (during hospitalization).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
F-QRS measurements
Time frame: Over 6 months
recorded from ECG
2 secondary outcomes
Left ventricular ejection fraction (LVEF)
Time frame: Over 6 months
T-Troponin tests
Time frame: Over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: No. No IPD will be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Kelly principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F-QRS measurements (time frame: Over 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.